Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on LED technology and basic timing controls, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The device is intended for "treating wrinkles," which constitutes a therapeutic use.

Diagnostic

No

The "Intended Use / Indications for Use" states that the device is "intended for use in treating wrinkles within the periorbital region," which is a therapeutic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the main unit device, charging base, USB charging cord, velcro straps, goggles, and LEDs. It also describes the physical mechanism of action (emitting light) and power intensity, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "treating wrinkles within the periorbital region." This is a therapeutic use, not a diagnostic one.
Device Description: The device is an LED light therapy device that applies energy to the skin. It does not analyze biological samples (like blood, urine, or tissue) which is the hallmark of an IVD.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

Product codes

OHS

Device Description

The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time.

The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles.

There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm².

The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment.

There are no differences between the two models other than the output wavelength.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

periorbital region

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-Counter (OTC) use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

LED Eye Perfector (Model: EY-36A, EY-36B) has been evaluated the safety and performance by lab bench testing as following:

Standards No.	Standard Title	Version	Date	Recognition Number
ANSI AAMI ES60601-1	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	07/09/2014	19-4
IEC 60601-1-11	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	Edition 2.1 2020-07	12/21/2020	19-38
IEC 60601-2-57	Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use	Edition 1.0 2011-01	03/16/2012	12-242
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	Edition 4.1 2020-09	12/21/2020	19-36
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	Edition 3.2 2020-07	12/21/2020	5-132
IEC 62471	Photobiological safety of lamps and lamp systems	First edition 2006-07	08/20/2012	12-249
IEC 62133-2	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems	Edition 1.0 2017-02	12/23/2019	19-33
ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Third edition 2009-06-01	12/23/2016	2-245
ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Third Edition 2010-08-01	07/26/2016	2-174

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K171386, K162489

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 8, 2022

Light Tree Ventures Europe B.V. Kim Laurens Manager Laan van Ypenburg 108, 2497 GC The Hague, Netherlands

Re: K221444

Trade/Device Name: LED Eye Perfector, model: EY-36A, EY-36B Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS Dated: November 10, 2022 Received: November 10, 2022

Dear Kim Laurens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, bold font. The text is black and appears to be centered. The background is white, and there is a faint watermark behind the text.

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K221444

Device Name LED Eye Perfector (Model: EY-36A, EY-36B)

Indications for Use (Describe)

The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of K221444

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com

Distributor

Company Name: CurrentBody.com Ltd Address: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme SK8 6QH

Factory

Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town,Baoan District, Shenzhen, Guangdong, 518103, China

Application Correspondent:

Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com

2. Subject Device Information

Trade Name: LED Eye Perfector, model: EY-36A, EY-36B Trademark: CurrentBody SkinTM Classification Name: Light Based Over-The-Counter Wrinkle Reduction Review Panel: General & Plastic Surgery Product Code: OHS

4

Regulation Number: 21 CFR 878.4810 Regulation Class: II

3. Predicate Device Information

Predicate Device (Primary comparison device) Sponsor: LED Technologies, Inc Trade Name: dpl® SpectraLite Classification Name: Light Based Over-The-Counter Wrinkle Reduction Common Name: dpl® SpectraLite 510(K) Number: K171386 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II

Predicate Device (Second comparison device)

Sponsor: Zhongshan Bisen Plastic Electronic Products Co., Ltd. Trade Name: RED Light Device Classification Name: Light Based Over The Counter Wrinkle Reduction Common Name: Light Emitting Diode (LED) Device 510(K) Number: K162489 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II

4. Device Description

The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time.

The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles.

There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm².

The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment.

5

There are no differences between the two models other than the output wavelength.

5. Intended Use / Indications for Use

The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

6. Comparison to predicate device and conclusion

Compare with the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.

| Elements of
Comparison | Subject Device | Predicate Device
(Primary
comparison
device) | Predicate
Device (Second
comparison
device) | Remark | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Light Tree Ventures Europe B.V. | LED Technologies, Inc | Zhongshan
Bisen Plastic
Electronic
Products Co.,
Ltd. | -- | |
| Trade Name | LED Eye Perfector | dpl® SpectraLite | RED Light
Device | -- | |
| Model | EY-36A EY-36B | EY-40 | BZ-0606 | -- | |
| Classification Name | Light Based Over-The-
Counter Wrinkle
Reduction | Light Based Over-
The-Counter
Wrinkle Reduction | Light Based
Over The
Counter Wrinkle
Reduction | Same | |
| 510(k) Number | Applying | K171386 | K162489 | -- | |
| Product Code | OHS | OHS | OHS | Same | |
| Intended Use /
Indications for Use | The LED Eye Perfector
(Model: EY-36A, EY-
36B) is an Over-the-
Counter (OTC) device
intended for use in
treating wrinkles within
the periorbital region. | The dpl®
SpectraLite is an
Over-the-Counter
(OTC) device
intended for use in
treating wrinkles
within the | The RED Light
Device is an
OTC device
indicated to emit
energy in the red
and IR region of
the spectrum for | Same | |
| | | | periorbital region. | use in
dermatology for
the treatment of
periorbital
wrinkles. | |
| Power Supply | Main unit: 3.7V, 420mAh
lithium battery, 1.55Wh
Adapter Input: 100-
240Va.c., 50/60Hz
Adapter Output: 5Vd.c,
1A | | 120-240V 5VDC
Power
Adapter | Adaptor:100~24
0V AC 50/60Hz
Lithium battery:
2x3.7V | Similar
Note 1 |
| Wavelengths | 605 nm,
633 nm,
660nm,
830 nm | 605 nm,
625 nm,
660nm,
880 nm | 605 nm, 625 nm,
660nm,
880 nm | Red: 633 ±5nm
Infrared: 830
±5nm | Similar
Note 2 |
| Modes | On/Off | | On/Off | Not applicable | Same |
| Irradiance source | LED | | LED | LEDs | Same |
| Visible light LEDs | Yes | | Yes | Yes | Same |
| Treatment Area | 40 cm² | | 28 cm² | 17cm² | Different
Note 2 |
| Energy Level | 65 mW/cm² | | 61.59 mW/cm² | 125 mW/cm²
70 mW/cm²
(633 nm);
55 mW/cm²
(830 nm) | Different
Note 2 |
| LED distribution | Uniform
distribution | Uniform
distribution | Uniform distribution | No publicity | Same |
| Treatment Time | 3 minutes per treatment | | 3 minutes per
treatment | For the first
month (4
weeks),
treatment should
be performed 3
times a week for
15-20 minutes | Same |
| | | | each time. (5-7
minutes on each
treatment zone). | | |
| Target Population | Individuals with wrinkles
on their face within the
periorbital region. | Individuals with
wrinkles on their
face within the
periorbital region. | Individuals with
periorbital lines
and wrinkles | Same | |
| Location for USE | OTC | OTC | OTC | Same | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same | |
| Safety | IEC 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 62471 | IEC 60601-1,
IEC 62471 | IEC 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 62471 | Same | |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | Same | |

6

7

Comparison in Detail(s):

Note 1: Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.

Note 2: Although the "Wavelengths", "Treatment Area" and "Energy Level" are a little different from the predicate devices, they all complied with the IEC 60601-1-2, IEC 60601-2-57, and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.

7. Test Summary

LED Eye Perfector (Model: EY-36A, EY-36B) has been evaluated the safety and performance by lab bench testing as following:

Standards No.	Standard Title	Version	Date
ANSI AAMI
ES60601-1	Medical electrical equipment -
Part 1: General requirements
for basic safety and essential
performance	2005/(R)2012 and
A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012	07/09/2014	19-4
IEC 60601-1-11	Medical electrical equipment -
Part 1-11: General
requirements for basic safety
and essential performance -
Collateral Standard:
Requirements for medical
electrical equipment and
medical electrical systems
used in the home healthcare
environment	Edition 2.1 2020-07	12/21/2020	19-38
IEC 60601-2-57	Medical Electrical Equipment

Part 2-57: Particular
requirements for the basic
safety and essential
performance of non-laser
light source equipment
intended for therapeutic,
diagnostic, monitoring and
cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 | 12-242 |
| IEC 60601-1-2 | Medical electrical equipment -
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances
Requirements and tests | Edition 4.1 2020-09 | 12/21/2020 | 19-36 |
| IEC 60601-1-6 | Medical electrical equipment -
Part 1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability | Edition 3.2 2020-07 | 12/21/2020 | 5-132 |
| IEC 62471 | Photobiological safety of
lamps and lamp systems | First edition 2006-07 | 08/20/2012 | 12-249 |
| IEC 62133-2 | Secondary cells and batteries
containing alkaline or other
non-acid electrolytes - Safety
requirements for portable
sealed secondary cells, and
for batteries made from them,
for use in portable
applications – Part 2: Lithium
systems | Edition 1.0 2017-02 | 12/23/2019 | 19-33 |
| ISO 10993-5 | Biological evaluation of
medical devices - Part 5:
Tests for in vitro cytotoxicity | Third edition 2009-
06-01 | 12/23/2016 | 2-245 |
| ISO 10993-10 | Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization | Third Edition 2010-
08-01 | 07/26/2016 | 2-174 |

8

9

8. Date of the summary prepared: November 10, 2022

9. Final Conclusion:

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K171386 and K162489.